Job Description
The Biologics Technical product leader role is responsible for technical leadership and oversight for all biologics molecules end to end. This includes both pipeline and in line products. For pipeline, this includes development and implementation of pipeline commercialization strategy to ensure on-time launch with the best science and most robust processes working closely with Development and Commercialization Review Committee (DCRC). For inline, this includes development and implementation of technology roadmaps that proactively ensure reliable supply in alignment with the franchise objectives as developed by the value chain team for each product.
This role ensures ownership for the products’ technical processes and associated technical challenges.
Primary Responsibilities:
Managing the portfolio of technical projects associated with the Biologics products. Using standard tools and processes to enable prioritization, resource allocation and ensure project outcome realization.
Working collaboratively with the Global Biologics and Sterile Operating Unit (GBO OpU) and associated Value Chain Management Team (VCMT) to align on prioritization and strategies for the delivery of the business needs, in particular for the in line products. Ensuring that the team works with urgency to support the E2E supply chain when issues arise to ensure minimal risk to supply or compliance.
Developing tools and processes to ensure we are holistically looking at our products and their performance, using data to inform us of stability concerns or potential risks to our compliance posture or continuity of supply
Provide deep technical oversight of projects within the technical portfolio of products in partnership with the broader Large Molecule Science & Technology (LMS&T) organization. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by teams supporting in line and pipeline products. Expectation is that this leader will provide a structured approach to technical leadership that enables clear prioritization of the work aligned with the business needs, working with key stakeholders and decision makers.
Coaching and developing the technical leaders so they are able to support organization and all the complexity that exists today. Ensuring team are continuing to develop their knowledge and skills. It is required that this leader will create an environment through expectations, culture and processes which nurtures and demands both technical excellence and executional excellence. Ensuring reliable launch and sustained supply are achieved and there is both technical knowledge continuity and technical project continuity as the product passes from pipeline to inline.
Required to comply with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture in Global Science, Engineering and Commercialization (GSEC) and within the teams that they interact with.
May be required to perform other duties as assigned.
Education Minimum Requirement:
B.S. /M.S. /Ph.D. in one of the relevant Engineering or Science fields
Required Experience and Skills:
Minimum of 10 years experience in biopharmaceutical manufacturing and/or development, preferably a majority spent in science and technical role.
Demonstrated technical excellence an in depth understanding of biologics molecules, manufacturing processes and commercialization principles
Experience of biologics development and new product introduction.
Strong cross divisional networking skills and capabilities
Experience in Technical product stewardship an advantage
Demonstrated functional and enterprise leadership, ability to influence at all levels of the organisation.
Strong collaborative and talent-building skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment
Core Competences:
Technical
Deep knowledge and experience of working in a leadership role in the manufacture and/or development of biologic drug substance and/or drug product is required
Proven record in technical problem solving in a complex manufacturing environment
Proven record in project/portfolio management
Experience in on time delivery of E2E Pipeline programs
Knowledge and experience in ADC’s an advantage
Business
Manage a budget for the team of approximately 20/30 people
Maintain a focus on COGs and work with the OpU’s to continuously see where improvements can be made year on year
Ensure alignment of the teams portfolio of projects with the business strategy and associated priorities
Leadership
Focus on Customers and Patients
Strong communications and collaboration skills
Act with Candor and Courage
Make Rapid, Disciplined Decisions
Drive Results
Build Talent
Demonstrate Ethics and Integrity
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/12/2025
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